Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Immunology | Hepatology (Liver, Pancreatic, Gall Bladder) | Infections and Infectious Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved June 1996
Treatment Area: Mycobacterium avium complex (MAC)
Zithromax has been approved for the treatment of Mycobacterium
avium complex (MAC) in subjects with advanced HIV infection.
Zithromax is taken in a once-weekly 1200 mg dose (two 600 mg
Clinical trials document that prophylaxis with once-weekly
Zithromax reduced the risk of developing MAC bacteria in the
bloodstream and the clinical signs and symptoms associated with
Two randomized, double-blind trials conducted in people with
advanced HIV infection demonstrated that Zithromax effectively
reduced the risk of developing disseminated MAC. In one of these
pivotal studies, Zithromax was compared to rifabutin and the
combination of these two agents. In this large double-blind study,
there was a statistically significant difference in favor of
Zithromax in the one-year cumulative incidence rate of disseminated
MAC. Additionally, Zithromax-rifabutin combination therapy was to
be more effective than rifabutin as monotherapy.
Formal drug interaction studies have demonstrated that Zithromax
can be used concomitantly with many medications commonly prescribed
for subjects with advanced HIV infections, such as zidovudine,
didanosine, or rifabutin, without dosage adjustments. Currently, no
data are available evaluating the concomitant use of Zithromax and
the recently approved protease inhibitors.
Overall side effects in Zithromax-treated subjects were
primarily mild to moderate in nature and consisted mainly of
diarrhea, nausea, abdominal pain, and loose stools.
Gastrointestinal side effects observed in subjects treated with
Zithromax were statistically greater than those observed in the
rifabutin-treated subjects. There was no statistically significant
difference in discontinuations due to side effects among the
Zithromax is contraindicated in subjects with known
hypersensitivity to azithromycin, erythromycin, or any macrolide
MAC is the most common systemic bacterial infection in persons
with advanced AIDS: MAC has been confirmed post-mortem in more than
50% of persons with advanced HIV infection, and the U.S. Centers
for Disease Control and Prevention estimates that one in every four
persons living with AIDS has disseminated MAC. Caused by the M
avium bacterium, disseminated MAC infection results in symptoms
that include fever, night sweats, fatigue, abdominal pain, chronic
diarrhea, and weight loss or "wasting."